Patient Education in Adherence on Acne (PEAce)

Acne Clinical Trial

Official title:

Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307266
• Other study ID #: RD.03.SPR.102710
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects age of 12 years or older,

2. With facial acne vulgaris that can be managed in primary care

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study,

2. Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Behavioral:
• Standard of care + supplementary education

• Standard of care + additional visits

• Standard of care

Locations

Country	Name	City	State
United Kingdom	Swan Lane Medical Centre	Bolton
United Kingdom	Burbage Surgery	Burbage
United Kingdom	South Axholme Practice	Epworth
United Kingdom	Dr Moss and Partners	Harrogate
United Kingdom	Barlow Medical Centre	Manchester
United Kingdom	Leicester Terrace Health Care Centre	Northampton
United Kingdom	University of Nottingham Health Service	Nottingham
United Kingdom	Rothwell and Desborough Healthcare Group	Rothwell
United Kingdom	Albany House Medical Centre	Wellingborough
United Kingdom	Whitby Group Practice	Whitby

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)	To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.; Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.	week 12